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Sponsors and Collaborators: |
Asker & Baerum Hospital Helse Ost Ullevaal University Hospital AstraZeneca |
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Information provided by: | Asker & Baerum Hospital |
ClinicalTrials.gov Identifier: | NCT00130975 |
The purpose of this study is to test the hypothesis that treatment with the angiotensin II type 1 receptor antagonist candesartan may reduce the recurrence rate of atrial fibrillation after electrical cardioversion.
Condition | Intervention | Phase |
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Atrial Fibrillation |
Drug: Candesartan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 200 |
Study Start Date: | April 2001 |
Estimated Study Completion Date: | September 2005 |
Background: The most effective procedure to restore sinus rhythm in patients with persistent atrial fibrillation (AF) is electrical cardioversion, but AF recurs in 60-80% of the patients during the first year. AF is associated with electrical and anatomical remodelling of the atria, and angiotensin II is involved in the remodelling process. Studies have indicated that the angiotensin II type 1 receptor antagonist candesartan may counteract both electrical and anatomical remodelling induced by AF. The investigators therefore hypothesised that treatment with candesartan may reduce the recurrence rate of AF after electrical cardioversion.
Study design: 171 patients with persistent AF scheduled for electrical cardioversion are randomised in a double blind, placebo-controlled study. The patients receive tablets of candesartan 8 mg or matching placebo once daily for 3-6 weeks before cardioversion, and candesartan 16 mg or matching placebo once daily for 6 months after cardioversion. The study medication is discontinued if electrical cardioversion is unsuccessful or if AF recurrence is documented. Primary endpoint is recurrence of AF. Clinical, electrocardiographic, echocardiographic and biochemical markers will be analysed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Asker & Baerum Hospital | |
Rud, Norway, 1309 | |
Ulleval University Hospital | |
Oslo, Norway, 0407 |
Principal Investigator: | Arnljot Tveit, MD | Asker & Baerum Hospital |
Study ID Numbers: | CAPRAF |
Study First Received: | August 16, 2005 |
Last Updated: | January 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00130975 |
Health Authority: | Norway: Norwegian Medicines Agency |
Atrial fibrillation. Cardioversion. Recurrence. Candesartan. |
Candesartan cilexetil Heart Diseases Candesartan Atrial Fibrillation |
Angiotensin II Recurrence Arrhythmias, Cardiac |
Angiotensin II Type 1 Receptor Blockers Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |